NCT00355966

Brief Summary

Induction of labour with vaginal misoprostol, in women with premature rupture of membranes at term, results in significant shortening of induction to delivery time in comparison to vaginal PGE2 gel induction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 25, 2010

Status Verified

November 1, 2008

Enrollment Period

2.1 years

First QC Date

July 18, 2006

Last Update Submit

March 24, 2010

Conditions

Premature Rupture of Membranes at Term

Keywords

Premature rupture of membranesInduction of labour with MisoprostolInduction of labour with PGE2 gel

Outcome Measures

Primary Outcomes (1)

  • Admission to delivery time

    48 hours

Secondary Outcomes (3)

  • Caesarean Section rate

    48 hours

  • Neonatal morbidity

    Till discharge

  • Maternal morbidity

    Till discharge

Study Arms (2)

A

ACTIVE COMPARATOR

In group A, immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .

Drug: Misoprostol

B

ACTIVE COMPARATOR

In Group B immediate induction of labour will be done by application of vaginal PGE2 gel 0.5 gm at an interval of 6 hours , a maximum of 2 doses.

Drug: PGE2 gel

Interventions

MisoprostolDRUG

In one group of women immediate induction of labour will be done by intravaginal misoprostol 25 microgram 4 hourly , a maximum of 5 doses .

A
PGE2 gelDRUG

In other group immediate induction of labour will be done by intravaginal application of PGE2 gel 0.5 mg at an interval of 6 hours , a maximum of 2 doses.

B

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Premature rupture of membranes at 37 or more weeks
  • Single live fetus in cephalic presentation

You may not qualify if:

  • Women in labour
  • Women with contraindication of induction of labour
  • Women with previous caesarean section or uterine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NRS Medicl College,138 AJC Bose Road

Kolkata, West Bengal, 700014, India

Location

Related Links

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

MisoprostolDinoprostone

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsProstaglandins E

Study Officials

  • Snehamay Chaudhuri, MBBS,MD,DNB

    NRS Medical College , Kolkata, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 25, 2006

Study Start

August 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 25, 2010

Record last verified: 2008-11

Locations

IN(1)